BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    Xpert Knee

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690117520·Distal Reamer (Hudson)

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690111658·Modular Stem 15mm x 150mm

    Stage 1

    FDA UDI
    KEYSTONE DENTAL, INC.·D768S2501551K0·COC Abutment

    POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    NOVA Lite DAPI ANA Kit

    FDA 510(k)
    FDA Class 2 ·Immunology

    Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243

    FDA Enforcement
    Class II ·Ongoing·CORIN MEDICAL, LTD.·July 9, 2025

    OT PING METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·September 15, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 26, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·August 22, 2013

    Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243

    FDA Recall
    Open, Classified ·CORIN MEDICAL, LTD. Unit 1-57-8 Corinium Centre Cirencester United Kingdom·Product code JWH·May 23, 2025

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013